Can a birch bark gel soothe blistering skin disease?
NCT ID NCT07756138
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This pilot trial is testing whether a topical gel called Filsuvez, made from birch triterpenes, is safe and helpful for people aged 6 months and older with moderate-to-severe epidermolysis bullosa simplex (EBS), a condition causing fragile skin and blisters. Participants will apply the gel to about 3% of their body surface for three months. The study aims to see if the gel reduces blistering, helps wounds heal faster, and improves comfort by lessening pain and itching.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Filsuvez (birch triterpenes) topical gel
- What this could lead to
- If successful, this could point toward a new topical treatment to reduce blistering, speed wound healing, and ease pain and itching for people with epidermolysis bullosa simplex.
- What could go wrong
- This is a small pilot study with only 10 participants, so results may not apply broadly. The gel's effectiveness and safety are still uncertain, and it may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject has a documented diagnosis and confirmed clinical history of EBS. The Investigator will determine subject eligibility based on historical phenotypic presentation of EBS symptoms along with genetic/diagnosis documentation in order to determine EBS severity. * The following skin conditions are required: * A minimum area of \~3% BSA containing active blisters/erosions, and freshly ruptured blisters across 50% of the TLA (as assessed by the PI). Skin erosions, keratoderma, fissures and/or erythema may also be present. * Subjects will be permitted to treat their feet to assess plantar blister surface area but blistering on the feet is not a requirement for study inclusion. * TLA may not be infected (as assessed by PI) or have been treated with a topical antibiotic within 14 days. * If the subject is a woman of childbearing potential (WOCBP) (Need to verify current labeling on use during pregnancy) * Has a negative urine pregnancy test at baseline. * Agrees to use an approved effective form of birth control with failure rates \<1% per year (e.g., implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomized partner) during participation in the study. * Is not nursing. * Subject's laboratory values (blood and urine) are within the range of normal or abnormal values are within normal levels for the disease and in the opinion of the PI the values are not clinically relevant for study participation. * Subject is in good, general health and free of any known disease state or physical condition which, in the investigator's opinion, might interfere evaluation of the EBS lesions during study or which exposes the subject to an unacceptable risk by study participation. * Over the duration of the study, the subject agrees to not use any other topical therapies and/or impregnated dressings within the TLAs (e.g., medicated cleansers, CBD oil, MediHoney, Silvadene cream 1%, topicals containing antimicrobials, keratin, and/or collagen, lipid-colloid or polymeric membrane dressings, and/or hydrogels). * Subject and/or legally appointed and authorized representative must be able and willing to follow study procedures and instructions to maintain compliance throughout the study period. * The subject, parent, or legally appointed and authorized representative must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent and Assent Form if applicable. Exclusion Criteria: * Subject's use of prior or concomitant medication or medical treatments/procedures: * Any investigational drug or therapy within 30 days. * Systemic steroidal therapy within 30 days. * Topical steroidal therapy in TLA within 14 days (Note: inhaled and ophthalmic products containing steroids are allowed). * Systemic antibiotic therapy within 7 days. * Currently receiving chemotherapy or radiation. * Surgery within the previous 2 weeks (except for minor surgery, cosmetic or dental procedures as determined by the investigator). * Started to take chronic medications (NSAIDs, antihistamines, etc.) at least 30 days prior to starting study medication. * Subject's medical history includes: * Cancer that is currently undergoing treatment. * Current systemic or ongoing skin infection. * HIV/AIDS. * Non-EBS skin disease (e.g., psoriasis, atopic dermatitis, etc.), or condition (e.g., sunburn) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study medication application or the study assessments. * An illness (e.g., neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease), condition, or situation that in the opinion of the principal investigator is likely to interfere with the subject's participation in or completion of the study. * Factors present in the subject and/or his/her legal representative that could interfere with study compliance such as inability to attend scheduled study visits or to perform study protocol procedures. * Subject is a member of the investigational team or his/her immediate family. * Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University School of Medicine
Palo Alto, California, 94304, United States
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